FDA UDI
In Commercial Distribution
🇺🇸 United States
WALGREENS
DI: 00311917130347
·
Model: QPZ-01
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WALGREENS
- Primary DI
- 00311917130347
- Version / Model
- QPZ-01
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-06
- Public Version
- 1
- Public Version Date
- 2023-03-14
- Public Version Status
- New
- Public Device Record Key
- f697cff7-cdc6-4860-ae50-9948248f5dda
Device Description
COLD SORE DEVICE REUSABLE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKJ | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | General, Plastic Surgery | 878.4860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52750 | Infrared-light cold sore treatment device | A hand-held, battery-powered, portable device designed to be used by a layperson to emit infrared light intended as therapy to reduce the duration of cold sores caused by the herpes virus (herpes labialis). It typically consists of a self-contained unit, light-emitting diodes (LEDs), an internal microprocessor and software, activation control and signal light, and disposable batteries. Upon application, it emits infrared light (wavelengths around 1072 nm) to the dermis of the affected area of an erupting cold sore for a pre-set period of time (e.g., few minutes) and provides a signal to the user when the treatment is complete. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10031191713032 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00311917130347 | GS1 |
Customer Contacts
- Phone
- 1-844-968-3223
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222205 | 000 |